Cleared Traditional

K780372 - CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS. (FDA 510(k) Clearance)

K780372 · Abbott Laboratories · Chemistry device
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May 1978
Decision
56d
Days
-
Risk

K780372 is an FDA 510(k) clearance for the CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS..

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K780372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1978
Decision Date May 03, 1978
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -